Akeso (9926) ESMO 2024 Presentation summary

Study design and patient characteristics

• Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, was evaluated with chemotherapy in 30 patients with locally advanced unresectable or metastatic TNBC, median follow-up 10.12 months.

• Patients had no prior systemic therapy for advanced TNBC; 60% had prior taxane-based neoadjuvant/adjuvant therapy, and 53.3% had ECOG PS 1.

• 80% of patients had PD-L1 CPS <10, and 53.3% had PD-L1 CPS <1.

• Median age was 54 years; 63.3% had recurrent/metastatic disease, and 23.3% had liver metastases.

Efficacy outcomes

• Overall response rate (ORR) was 72.4%, with 6.9% complete response and 65.5% partial response.

• Disease control rate (DCR) reached 100%, and median progression-free survival (PFS) was 9.3 months.

• Six-month duration of response rate was 68.9%, and six-month PFS rate was 73.3%.

• In PD-L1 CPS <10 subgroup, ORR was 69.6% and median PFS was 9.3 months; in CPS ≥10, ORR was 83.3%.

Safety profile

• Most common treatment-related adverse events (TRAEs) were hematologic and liver enzyme abnormalities, mainly grade 1-2.

• 53.3% experienced grade ≥3 TRAEs, but no TRAEs led to permanent discontinuation or death.

• Serious TRAEs occurred in 30% of patients; common events included decreased white blood cell and neutrophil counts, and elevated liver enzymes.